The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls | FDA

The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls | FDA

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September 30, 2020

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution (Updated - Currently in Shortage)
• The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Guidance for Industry

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

September 29, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Lumigan NDA #022184	Bimatoprost	Solution/Drops; Ophthalmic	SUPPL-8	Allergan	Labeling	Approved
Latisse NDA #022369	Bimatoprost	Solution/Drops; Topical	SUPPL-12	Allergan	Labeling	Approved
Indocyanine Green ANDA #040811	Indocyanine Green	Injectable; Injection	SUPPL-6	Diagnostic Green	Labeling	Approved
Almotriptan Malate ANDA #078027	Almotriptan Malate	Tablet; Oral	SUPPL-2	Teva Pharms Usa	Labeling	Approved
Almotriptan Malate ANDA #078027	Almotriptan Malate	Tablet; Oral	SUPPL-2	Teva Pharms Usa	Labeling	Approved
Heparin Sodium ANDA #091682	Heparin Sodium	Injectable; Injection	SUPPL-13	Sandoz	Labeling	Approved
Simponi Aria BLA #125433	Golimumab	Injectable; Injection	SUPPL-30	Janssen Biotech	Efficacy	Approved
Simponi Aria BLA #125433	Golimumab	Injectable; Injection	SUPPL-31	Janssen Biotech	Efficacy	Approved
Unituxin BLA #125516	Dinutuximab	Injectable; Intravenous	SUPPL-25	United Therap	Labeling	Approved
Unituxin BLA #125516	Dinutuximab	Injectable; Intravenous	SUPPL-25	United Therap	Labeling	Approved
Heparin Sodium ANDA #201002	Heparin Sodium	Injectable; Injection	SUPPL-9	Sandoz	Labeling	Approved
Lapatinib Ditosylate ANDA #203007	Lapatinib Ditosylate	Tablet; Oral	ORIG-1	Natco Pharma Ltd		Approved
Albuterol Sulfate ANDA #203760	Albuterol Sulfate	Aerosol, Metered; Inhalation	SUPPL-2	Perrigo Pharms Co	Manufacturing (CMC)	Approved
Proair Digihaler NDA #205636	Albuterol Sulfate	Powder, Metered; Inhalation	SUPPL-20	Teva Branded Pharm	Labeling	Approved
Proair Digihaler NDA #205636	Albuterol Sulfate	Powder, Metered; Inhalation	SUPPL-20	Teva Branded Pharm	Labeling	Approved
Proair Respiclick NDA #205636	Albuterol Sulfate	Powder, Metered; Inhalation	SUPPL-20	Teva Branded Pharm	Labeling	Approved
Proair Respiclick NDA #205636	Albuterol Sulfate	Powder, Metered; Inhalation	SUPPL-20	Teva Branded Pharm	Labeling	Approved
Dolutegravir ANDA #209565	Dolutegravir	Unknown	ORIG-1	Hetero Labs Unit Iii		Tentative Approval
Heparin Sodium ANDA #211004	Heparin Sodium	Injectable; Injection	SUPPL-3	Nanjing King-Friend	Labeling	Approved
Heparin Sodium ANDA #211005	Heparin Sodium	Injectable; Injection	SUPPL-3	Nanjing King-Friend	Labeling	Approved
Eslicarbazepine Acetate ANDA #211238	Eslicarbazepine Acetate	Unknown	ORIG-1	Dr Reddys Labs Ltd		Tentative Approval
Alkindi Sprinkle NDA #213876	Hydrocortisone	Capsule; Oral	ORIG-1	Diurnal Ltd	Type 3 - New Dosage Form	Approved
Atropine Sulfate NDA #214652	Atropine Sulfate	Solution; Injection	ORIG-1	Accord Hlthcare	Type 5 - New Formulation or New Manufacturer	Approved

September 28, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Tekturna Hct NDA #022107	Aliskiren Hemifumarate; Hydrochlorothiazide	Tablet; Oral	SUPPL-34	Noden Pharma	Labeling	Approved
Tekturna Hct NDA #022107	Aliskiren Hemifumarate; Hydrochlorothiazide	Tablet; Oral	SUPPL-34	Noden Pharma	Labeling	Approved
Norepinephrine Bitartrate ANDA #040455	Norepinephrine Bitartrate	Injectable; Injection	SUPPL-22	Teva Pharms Usa	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-40	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-35	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-36	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-39	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-40	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-42	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-42	Apnar Pharma Lp	Labeling	Approved
Thiamine Hydrochloride ANDA #080575	Thiamine Hydrochloride	Injectable; Injection	SUPPL-19	West-Ward Pharms Int	Manufacturing (CMC)	Approved
Thiamine Hydrochloride ANDA #080575	Thiamine Hydrochloride	Injectable; Injection	SUPPL-19	West-Ward Pharms Int	Manufacturing (CMC)	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-48	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-49	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-51	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-54	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-56	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-57	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-60	West-Ward Pharms Int	Labeling	Approved
Docetaxel ANDA #210327	Docetaxel	Injectable; Injection	SUPPL-1	Shilpa Medicare Ltd	Labeling	Approved
Docetaxel ANDA #210327	Docetaxel	Injectable; Injection	SUPPL-2	Shilpa Medicare Ltd	Labeling	Approved
Docetaxel ANDA #210327	Docetaxel	Injectable; Injection	SUPPL-3	Shilpa Medicare Ltd	Labeling	Approved
Bupropion Hydrochloride ANDA #211347	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-1	Yichang Humanwell	Labeling	Approved
Bupropion Hydrochloride ANDA #211347	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-1	Yichang Humanwell	Labeling	Approved